Reomen Tablet
Clomiphene Citrate
50mg
Eskayef Pharmaceuticals Ltd.
| Pack size | 20's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 10.00 AED |
Available as:
Indications
Reomen Tablet is used for:
Ovulation induction, Female infertility, Polycystic ovary syndrome, Amenorrhea-galactorrhea syndrome, Psychogenic amenorrhea
Adult Dose
Oral
Anovulatory infertility
Adult: 50 mg daily for 5 days starting on the 5th day of menstrual cycle or at any time if there is amenorrhea.
If ovulation does not occur, a 2nd course of 100 mg for 5 days may be used commencing as early as 30 days after the previous therapy.
Lower doses of 12.5-25 mg once daily may be administered in women sensitive to the drug or who consistently develop large ovarian cysts
Further treatment may not be recommended if pregnancy has not occurred after a total of 6 treatment cycles.
Child Dose
Renal Dose
Administration
May be taken with or without food.
Contra Indications
Clomiphene citrate is contraindicated during pregnancy, in patients with liver diseases, ovarian cysts, bleeding of undetermined origin, patients with neoplasm of endometrium, hypersensitivity; abnormal bleeding; lactation; uncontrolled thyroid or adrenal dysfunction, patient with an organic intracranial lesions such as pituitary tumor.
Undiagnosed abnormal uterine bleeding
Uncontrolled thyroid or adrenal dysfunction
Endometrial cancer
Ovarian cysts not due to PCOS
Presence of organic intracranial lesion, including pituitary tumor
Precautions
Uterine fibroids, pituitary or ovarian failure may occur
Potential for multiple births, especially at 100 mg dosage
Use should be supervised by a practitioner with training and thoroughly familiar with infertility problems and their management
Risk of visual disturbance (like scotoma & photopsia); patients should be warned that visual symptoms may render activities such as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting; while etiology of visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have complete ophthalmological evaluation carried out promptly
Cases of hypertriglyceridemia reported; preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment are associated with risk of hypertriglyceridemia; periodic monitoring of plasma triglycerides is recommended in patients with preexisting or family history of hyperlipidemia; pretreatment screening of triglyceride levels is recommended in patients initiating therapy
Cases of pancreatitis reported
Prolonged use of clomiphene citrate tablets USP may increase risk of a borderline or invasive ovarian tumor
Presence of organic intracranial lesion, including pituitary tumor
Ovarian enlargement may be accompanied by abdominal distention or abdominal pain and generally regresses without treatment within days or weeks of discontinuing therapy; withhold therapy if ovaries are abnormally enlarged until size returns to pretreatment size; reduce dose and duration of future cycles
Ovarian hyperstimulation syndrome
Ovarian hyperstimulation syndrome is a rare exaggerated response to ovulation induction therapy
May begin within 24 hours of treatment but may become severe 7 to 10 days after therapy
Monitoring Parameters
Reassess diagnosis after 3 courses if ovulation has not occurred or if menses does not occur following ovulatory response
Careful attention should be given to selection of candidates for therapy; pelvic examination is necessary prior to treatment and before each subsequent course
Pregnancy-Lactation
Pregnancy
Use in pregnant women is contraindicated, as treatment does not offer benefit in this population; to avoid inadvertent administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs; patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle; the next course of therapy should be delayed until these conditions have been excluded
Available human data from epidemiologic studies do not show apparent cause and effect relationship between clomiphene citrate periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly
Lactation
It is not known whether drug is excreted in human milk; because many drugs are excreted in human milk, caution should be exercised if drug is administered to a nursing woman; in some patients, therapy may reduce lactation
Interactions
Decreased response with danazol.
Contraindicated (1)
ospemifene
Adverse Effects
Side effects of Clomiphene Citrate :
>10%
Ovarian enlargement (14%),Vasomotor flushing (10%)
1-10%
Abdominal discomfort (6%),Blurred vision (1.5%),Breast discomfort (2%),Nausea/vomiting (2%)
Mechanism of Action
Clomifene inhibits the negative feedback mechanisms of oestrogens in the hypothalamus and pituitary which stimulates the secretion of pituitary gonadotrophic hormones resulting in stimulation of ovulation.
Note
Reomen 50mg Tablet manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Clomiphene Citrate. Reomen is availble in Bangladesh.
Farmaco BD drug index information on Reomen Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.